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Process for preparing micro Azithromycin powder

A technology of azithromycin and micronization is applied in the field of preparation of azithromycin ultrafine powder, which can solve the problems of dust pollution, static electricity, wide particle size distribution, particle agglomeration, etc., and achieves the effects of safe operation, controllable particle size and simple process

Inactive Publication Date: 2007-06-06
BEIJING UNIV OF CHEM TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The drug powder obtained by this method tends to have a wide particle size distribution, and due to the high energy input, it is easy to cause the agglomeration of the crushed particles
In addition, jet milling can also cause problems such as dust pollution and static electricity safety.

Method used

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  • Process for preparing micro Azithromycin powder
  • Process for preparing micro Azithromycin powder
  • Process for preparing micro Azithromycin powder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Adopt the commercially available azithromycin raw material drug that meets the requirements of the Pharmacopoeia, as shown in the scanning electron microscope (SEM) photo in Figure 1, the particle size is between 20-100 μm, and it is a particle with uneven particle size and irregular shape. Azithromycin crude drug is dissolved in dehydrated alcohol, is mixed with the azithromycin raw material solution (in this embodiment is the ethanol of azithromycin raw material) that concentration is 0.2g / ml (being 20 ℃ when azithromycin is in the about 50% of saturated concentration of azithromycin in ethanol). solution). The recrystallization temperature was controlled at 18°C ​​by a constant temperature water bath. Get the ethanol solution 10ml of above-mentioned azithromycin, add rapidly in the reactor that 200ml anti-solvent (water in this embodiment) is housed, that is, the volume ratio of azithromycin raw material solution and anti-solvent is 1: 20, under control stirring spee...

Embodiment 2

[0035] The operating parameters are the same as in Example 1, except that the recrystallization temperature is changed to 30°C. Observed by SEM, the particle morphology of the obtained azithromycin micronized product is similar to that of Example 1, but the average particle size of the particles is about 1 μm, and at least 80% of the particles have a particle size between 0.5-3 μm.

Embodiment 3

[0037]The operating parameters are the same as in Example 1, except that the volume ratio of the azithromycin raw material solution to the anti-solvent (water in this example) is changed to 1:10. Observation of the obtained product by SEM shows that the particle size of the product is basically between 0.5-1 μm, but the agglomeration is serious.

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Abstract

The process of preparing superfine Azithromycin powder belongs to the field of superfine medicine powder preparing technology. Specifically, the process includes marketable Azithromycin medicine material in organic solvent to obtain Azithromycin solution, adding the Azithromycin solution in counter solvent in certain volume through magnetic stirring at certain temperature to deposit Azithromycin crystal and obtain crystal slurry, ageing at certain temperature, filtering, washing and drying to obtain superfine Azithromycin powder product. The process is simple, safe, low in cost and suitable for industrial production, and the obtained superfine Azithromycin powder has high leaching rate and high solubility.

Description

technical field [0001] The invention belongs to the field of medicine ultrafine powder preparation, in particular to the preparation of azithromycin ultrafine powder. Background technique [0002] Azithromycin is a new type of macrolide antibiotic with a similar structure to erythromycin, but its antibacterial spectrum is wider than that of erythromycin, its antibacterial activity is stronger, and its chemical properties are more stable, especially its stability to acid is much higher than that of erythromycin. higher than erythromycin. Its chemical name is 9-deoxy-9α-aza-9α-methyl-9α-erythromycin A [CAS83905-01-5]. It was first invented by Bright (US Patent 4,474,768) and Kobrehel et al. (US Patent 4,517,357), and is mainly used for diseases caused by sensitive microorganisms. [0003] The marketed dosage forms of azithromycin mainly include oral dosage forms such as tablets, capsules, and dry suspensions. According to relevant literature reports, the oral bioavailabilit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7052A61K9/14A61P31/04
Inventor 陈建峰王国联邵磊王洁欣沈志刚
Owner BEIJING UNIV OF CHEM TECH
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